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Top Reasons SaMD 510(k)s Get AI Letters (and How to Fix Them)
Most SaMD 510(k)s hit a first-cycle Additional Information (AI) letter , not a final rejection. The recurring issues: missing...
Jun 247 min read
FDA De Novo Pathway Explained: The Complete 2025 Guide
The De Novo pathway provides marketing authorization for novel, low–to–moderate-risk devices without a predicate , creating a new...
Jun 236 min read
Pre-market Approval (PMA) Explained: The Complete 2025 Guide
Premarket Approval (PMA) is FDA’s most rigorous pathway, used for most Class III devices (those that support/sustain life, prevent...
Jun 209 min read
FDA 510(k) Clearance Explained: How It Works (2025 Guide)
A 510(k) premarket notification is how most moderate-risk devices show substantial equivalence to a legally marketed predicate . If...
Jun 197 min read
510(k) vs De Novo vs PMA: How to Choose the Right Pathway (2025)
Choosing an FDA pathway hinges on risk, novelty, and predicates. Use 510(k) when a suitable predicate exists for the same intended use...
Jun 124 min read
Clinical Evidence for SaMD: Valid Association, Analytical & Clinical Validation
To structure SaMD clinical evidence, build three pillars: valid clinical association (link SaMD output to the condition), analytical...
Jun 103 min read
FDA Software Validation 2025: What Evidence to Show
In 2025, FDA reviews a risk-based software evidence package per the Device Software Functions (DSF) guidance: choose Basic or Enhanced...
Jun 52 min read
Documenting AI-Enabled SaMD: What FDA’s Jan 2025 Draft Expects
FDA’s Jan 7, 2025 draft for AI-enabled device software functions recommends including: model description, dataset lineage/partitions...
Jun 33 min read
FDA SaMD Cybersecurity (2025): §524B, SBOM, Testing & eSTAR
In June 2025 FDA finalized its cybersecurity guidance and clarified §524B obligations for “ cyber devices .” For SaMD that connects to...
May 293 min read
IEC 62304 + ISO 14971 for SaMD: How to Integrate Lifecycle & Risk
Integrate IEC 62304 (software lifecycle) with ISO 14971 (risk management) by mapping hazards → requirements → design → tests →...
May 273 min read
FDA SaMD Pre-Submission (Q-Sub): When to Request & What to Include
Use an FDA Pre-Submission (Q-Sub) when your SaMD has novel tech/claims , unclear classification/pathway , clinical evidence questions,...
May 224 min read
FDA eSTAR for SaMD: What Changes After Oct 1 2025?
Starting October 1, 2025 , all De Novo requests for SaMD must be submitted using the FDA’s eSTAR template . This shift brings new module...
May 203 min read
Which FDA Pathway for SaMD? 510(k), De Novo, or PMA (2025)
Choosing a SaMD pathway depends on risk, novelty, and predicates . Use 510(k) when a suitable predicate exists for the same intended use...
May 153 min read
SaMD Risk Categories (IMDRF): What They Mean & How They Relate to FDA Review
IMDRF categorizes SaMD risk (I–IV) by crossing significance of information (inform, drive, treat/diagnose) with the condition’s...
May 133 min read
FDA Unique Device Identification (UDI): Complete Guide for Medical Device Manufacturers
FDA’s UDI system requires most device labels and packages to bear a Unique Device Identifier —in human-readable and AIDC...
Dec 6, 20244 min read
STeP for Medical Devices: FDA’s Safer Technologies Program Explained
FDA’s Safer Technologies Program (STeP) is a voluntary pathway for devices (and device-led combos) that are reasonably expected to...
Nov 26, 20246 min read
How Long Can FDA Approval Take? Understanding Timelines for Different FDA Pathways
For medical device companies, understanding the FDA approval timeline is critical. Knowing how long the process might take helps companies plan more accurately, manage resources effectively, and set realistic expectations for investors and stakeholders. However, the time to obtain FDA approval can vary significantly depending on the regulatory pathway and the complexity of the device. This guide provides a breakdown of typical timelines for the major FDA approval pathways—510
Nov 12, 20246 min read
FDA Q-Submission (Q-Sub) Program: How Early Feedback Streamlines Approval
The FDA Q-Submission (Q-Sub) Program lets device teams request written feedback or a meeting before and during submissions. Core types...
Nov 6, 20245 min read
FDA Compliance Guide for Medical Device Startups
Startups can meet FDA requirements without burning runway by sequencing the right decisions in the right order. This guide shows how to...
Nov 5, 20245 min read
Beginner’s Guide to FDA Compliance for Medical Devices
FDA regulates medical devices from classification through postmarket monitoring. This beginner’s guide shows how to determine class and...
Oct 22, 20246 min read
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